Montelukast Sodium
MONTELUKAST SODIUM TABLETS These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
ed2caffa-a75c-1c27-ae30-2d8280eaea7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Montelukast Sodium
PRODUCT DETAILS
NDC Product Code42291-622
Application NumberANDA200405
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2023
Generic NameMontelukast Sodium
INGREDIENTS (11)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 4 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Montelukast Sodium
PRODUCT DETAILS
NDC Product Code42291-621
Application NumberANDA201522
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2023
Generic NameMontelukast Sodium
INGREDIENTS (11)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 10 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Montelukast Sodium
PRODUCT DETAILS
NDC Product Code42291-623
Application NumberANDA200405
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2023
Generic NameMontelukast Sodium
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 5 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT